Stroke and neurological injuries are difficult and costly to treat problems. Four out of every five American families will be impacted by stroke and four million Americans live with the lingering effects of a stroke, making stroke the leading cause of serious, long-term adult disability in the United States. Further, of the approximately 795,000 people who suffer stroke each year in the United States approximately 144,000 die, 185,000 are recurrent attacks, and 466,000 are new cases. An estimated 33% of stroke survivors need help caring for them and 70% cannot return to their previous occupations. According to research by the American Heart Association (AHA) and Centers for Disease Control (CDC), the estimated 2009 direct and indirect cost to cover inpatient care, rehabilitation, and follow-up care for lasting deficits of a stroke was $68.9 billion (numbers converted to 1999 dollars using the medical component of CPI). In 2010 the effects of a stroke alone are projected to cost the United States nearly $73.7 billion.
Given the number of affected persons and considerable cost for their care, much work has been done to identify clinical practices yielding the most satisfactory outcomes for glenohumeral subluxations (GHS), a common stroke after effect. Research has found that proactive, early intervention focused on supporting and stabilizing a patient's shoulder complex is critical for two reasons: 1) proper biomechanical positioning of the shoulder reduces secondary damage to the shoulder joint and capsule, and 2) proper shoulder support and positioning ameliorates pain. Clinical therapists report pain is a primary obstacle faced when implementing rehabilitative techniques for the upper extremity. Understandably, patients in pain are mentally distracted, unable to remain positive about their situations, and hindered in participating in recommended therapeutic regimes. Conquering pain becomes yet another task on the tortuous path to stroke recovery. Thus, tools that help ameliorate pain and maintain the integrity of the shoulder capsule are of critical importance to the occupational therapist.
Hemiplegic shoulder pain (HSP) and shoulder subluxation, i.e., a partial or complete dislocation, are common complications after a stroke or other neurological injury. Shoulder pain can begin as early as 2 weeks post stroke and results in significant long-term disability that impedes rehabilitation intervention, and limits the patient's ability to reach their maximum functional potential. Shoulder subluxations affect up to 81% of patients with hemiplegic shoulder pain and often occur during a “flaccid stage” of stroke recovery, i.e., wherein the patient suffers severe sensory loss rendering the patient's arm limp and floppy. Improper positioning of the shoulder and lack of support of the upper arm when in an upright position can contribute to subluxation, which aggravates shoulder pain and other secondary shoulder injury or stroke complications. For the majority of occupational therapists, proactively managing shoulder pain and implementing effective biomechanical joint positioning to compensate for lost muscle tone in the upper arm is critical to increase tolerance for other neuro-rehabilitative techniques and to maintain normal length of surrounding muscle/soft tissue. Most occupational therapists use supports, slings, straps, or functional electrical stimulation for the early intervention of GHS, but traditional apparatus are sometimes ineffective.
Several slings and arm support systems have been developed to help stabilize the shoulder complex. Examples include the Omo Nuerexa (Otto Bock®, Minneapolis Minn.), the GivMohr® Sling (GivMohr Corp., Albuquerque N. Mex.), and the Arm Escort (Maddak®, Wayne N.J.). Shoulder slings generally employ a cradle that receives the lower part of the arm. A strap is attached at one end of the cradle, is looped around the patient's neck and is attached to another end of the cradle to maintain the arm in a desired position. The length of the strap in a typical sling may be adjusted to allow the lower arm to be positioned within a certain angular range relative to the upper arm. Lengthening the strap increases the angle of the lower arm further relative to the patient's midsection, but the range of positions is limited by the sling structure.
While effective in some circumstances, slings and other similar devices have not been widely accepted for several reasons: 1) complicated strap arrangements make donning difficult, particularly for the elderly, those with cognitive deficits, and those who lack caregiver support; 2) the patient's arm is suspended at or just proximal to the hand which results in inadequate support while seated, a substantial portion of the patient's day; 3) large regions of the shoulder, arm, and hand are covered or encapsulated, which interferes with natural thermal regulation and makes the patient uncomfortable; and 4) pressure is applied across the patient's ipsilateral trapezius or contralateral axillary region, which causes additional pain, skin irritation and breakdown, or muscle pathologies. One of skill in the art will appreciate that slings can potentially exacerbate an injury by immobilizing the lower arm, and, thus preventing internal humeral rotation, which is ideal for protecting suture lines, but which also promotes anterior subluxations. Furthermore, existing sling designs only promote proper alignment of the upper arm when the entire arm should have support in the form of shoulder protraction, humeral external rotation with abduction and flexion, forearm supination, neutral wrist, extended fingers, and thumb abduction. To address the deficiencies of the prior art, therapists frequently fabricate less-than-ideal support systems from materials such as pillows, towels, and foam wedges. Further, patients often make do with slings that only partially support the arm in one position (sitting or standing).
Within the upper-limb rehabilitation field there exists a recognized need for new arm support options, particularly ones that are comfortable that are intuitive and easy to use, can be readily donned (preferably independently by the patient), can reduce pain, can promote proper entire arm alignment, are compatible with other treatment interventions, and offer greater dynamic support when sitting, standing and ambulating. The following disclosure describes an improved support that maintains the patient's arm in a predetermined position and that elevates the head of the patient's humorous into the shoulder socket to reduce pain and secondary damage. The contemplated support also addresses the issues outlined above and other issues understood by those of skill in the art.